Transcriptional Analysis of Mechanisms in Liver Failure and Sepsis

Not yet recruiting

• Conditions: Acute Liver Failure; Sepsis

• Registration Number: NCT07131969
• Lead Sponsor: University of Cambridge

Brief Summary

Context Acute liver failure (ALF) is a life-threatening condition that occurs on the background of a healthy liver. The most common cause of acute liver failure in the UK is paracetamol overdose. Acute liver failure results from liver damage and activation of the body's inflammatory defences with subsequent damage to other organs including kidneys, lungs and heart. This often requires life support in an intensive care unit before liver transplantation (LT), the only currently available and effective rescue treatment for acute liver failure.

Challenge Patient factors and organ availability limit who can benefit from liver transplant. At present there are no effective alternative therapies for patients who do not get a liver transplant, and survival rates in these situations are poor. The underlying mechanisms of inflammation are poorly understood, thus therapies are limited.

Aim Our research aims to understand the mechanisms that underpin the inflammation seen in acute liver failure by studying the inflammatory cells in the blood and examining their cellular programmes. This will allow us to identify pathways that are activated and understand how the liver and blood interact to spread inflammation around the body. We aim to identify targets for disease-modifying therapies to avert the need for liver transplant.

Importance Understanding how the body responds to acute liver failure, and whether there are different patterns of inflammatory response, will enable trials of immune-modulating drugs to prevent the need for liver transplantation or prolong the time a patient can wait for an organ. This has the potential to help improve organ availability for other patients and save lives in acute liver failure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-09-01
• Primary Completion: 2027-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• acute liver failure due to acetaminophen (paracetamol) overdose admitted to ICU
• all cause sepsis admitted to ICU

Exclusion Criteria

• age <16y

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	From enrolment until at least 1-year

Secondary Outcome Measures

Name	Time	Method
Transplant free survival	From enrolment to at least one year	30-day and 1-year survival without transplant
Length of stay - ICU and hospital	From enrolment	Number of days stayed in ICU and in-hospital
Transplant free mortality	From enrolment until death (at least until 1year)	Death without transplant

Trial Locations

Locations (7)

University Hospitals Birmingham; 🇬🇧 Birmingham, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Kings College Hospital; 🇬🇧 London, United Kingdom

Royal Free Hospital; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom